In recent weeks, lawsuits have been filed in the US and Canada by men who claim their sexual functioning dramatically decreased after taking the Merck Propecia pill that is used to treat hair loss (read one here). Now, a study has reported for the first time that the medicine does, indeed, cause persistent sexual dysfunction, contradicting information disseminated by the drugmaker.
Here is the bottom line: the researchers interviewed 71 otherwise healthy men between the ages of 21 and 46 years old. These men reported the onset of sexual side effects associated with the use of the drug and in which symptoms continued for at least three months, despite having discontinued treatment. [The med, by the way, is called finasteride and Merck markets a higher dose called Proscar to treat enlarged prostates.]
To be specific, 94 percent developed low libido, 92 percent developed erectile dysfunction, 92 percent developed decreased sexual arousal and 69 percent developed problems with having an orgasm. The mean number of sexual episodes per month dropped from 25.8 to 8.8, and the total sexual dysfunction score on a standardized scale increased before and after using Propecia. At the time the interviews were conducted, the mean duration of the persistent sexual side effects was 40 months, with 20 percent of the participants reporting problems lasting more than six years.
By contrast, the US prescrbing information on the Propecia labels says that most men who experienced decreased libido, ejaculation disorder and erectile dysfunction were able to bounce back. "Resolution occurred in men who discontinued therapy with Propecia due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3 percent by the fifth year of treatment" (see page 9).
"This is the first trial to show this medication can cause persistent sexual side effects," says Michael Irwig of the Center for Andrology and Division of Endocrinology at The George Washington University and a co-author of the study, which was published in the Journal of Sexual Medicine (see the abstract). "And the risk needs to be known when men are contemplating taking the medication and doctors are prescribing the medication."
In other countries, the labeling is different. The UK's Medicines and Healthcare Products Regulatory Agency and the Swedish Medical Products Agency have both updated their patient info leaflets to include a statement that “persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use.”
"The looming question for all the subjects is whether their sexual function will ever recover. Many of the study participants have developed anxiety and depression as a consequence of their sexual dysfunction and all reported a significantly decreased quality of life, especially with dating and intimacy," the authors write.
They acknowledged, however, several limitations, including selection bias in which those subjects experiencing more severe side effects, or those for whom sexuality is a more significant aspect of their life, would be more likely to participate in a study looking at sexual parameters. Another limitation is recall bias. And they note the study does not prove that Propecia caused persistent sexual side effects.
Nontheless, they maintain that "the validity of our findings is supported by the known sexual side effects...in randomized, controlled trials, the temporal association of the onset of sexual dysfunction with the use..in otherwise healthy men, and the biological plausibility of the role of androgens and progestins in areas of the brain and peripheral nervous system associated with libido, orgasm and erectile function."
25 Comments
"The mean number of sexual episodes per month dropped from 25.8 to 8.8"
Sorry, I don't buy that...
So, let me understand this correctly:
- All the clinical trials leading to the registration of the product and, presumably, postmarketing after all these years showed that loss of libido, etc. was real but declined over time and was reversible on discontinuation
- Here, the author of the trial says "This is the first trial to show this medication can cause persistent sexual side effects" - based on an interview of 71 men.
Help me again? How is the company liable for what they did not know and looked for specifically and didn't find?
Ahhh, plaintiff lawyers are at it again (or still)...
To follow on the observation by keiner - 'There are lies, damn lies and STATISTICS.'
Based on even more statisitics,-
http://www.kinseyinstitute.org/resources/FAQ.html#frequency
- I would suggest that the subjects were outliers in this area to begin with and are now outliers (or perhaps 'out-liars" - pun) in the study covered above. As the authors observed:
"They acknowledged, however, several limitations, including selection bias in which those subjects experiencing more severe side effects, or those for whom sexuality is a more significant aspect of their life, would be more likely to participate in a study looking at sexual parameters."
And, actually, you never know - perhaps their (regular?) partners might find this a beneficial side effect?
This goes far beyond "selection bias." The enrollment criteria, per the abstract, included patients who experienced onset of sexual dysfunction while on treatment that persisted for at least 3 months after cessation. And what they found, lo and behold, is that these men had symptoms of sexual dysfunction & that they lasted longer than 3 months.
This is like studying whether or not people picked up on a DWI had been drinking before getting into the car. Where does the money come from for this nonsense?
THis isn't a study but an interview of patients after their use of the product was over. Don't see the point. THe researcher even admits that the drug may not have caused the problem which seems exagerated at best. If they have a competitor, the competitior will be using the comments.
I have been contemplating starting propocia but the internet has me so confused. My Dermatologist says he has prescribed to several of his patients with no side effects. Who do you beleive?
Please read my book "Clinical Pharmacology for Dummies" when it is published. There will be a scientific explanation for these side effects which I believe to be valid. Basically Propecia and Proscar reduce by approximately 2/3 the circulating levels of 5-alpha dihydrotestosterone (5-alpha DHT), which is responsible for the virilizing effects of testosterone. Drop your levels of DHT and you lose hair and libido, simple as that. In this case, outliers notwithstanding, I believe that the science is solid on this one.
Insider...you forgot one element of how biology plays out. Amazingly, our bodies have all kinds of compensatory mechanisms to ensure balance (homeostasis). That is why it makes sense that over time, some of the AEs tend to go away.
II-Not sure if I'm reading you correctly. Seems like you're saying that Propecia would make you lose hair, not prevent hair loss. This is not borne out by the evidence.
Undecided-Let's just say I know someone really, really well who has been using Propecia almost since the day it was approved, with good results & no AE's as yet. Surely there are others who haven't been so lucky, so it's important to work with your doctor on the risk:reward & take it from there, as with every therapy.
Salient, hair loss is due in part to 5-alpha Dihydroxy Testosterone (DHT), which is the active form of testosterone. Testosterone is converted in the body to DHT by an enzyme called 5 alpha reductase. Propecia blocks this enzyme form converting testosterone to DHT, hence lowerering the amount of DHT in the body. With lower levels of DHT there would arguably be less hair loss. Since DHT is also in part responsible for male libido, lower amounts of DHT, as caused by Propecia, wouls also corresponds to loower libido.
Hope this explains.
II-Yes, that makes sense. Your earlier comment said lower DHT leads to hair loss, which wasn't adding up.
The inverse relationship between hair loss & libido here seems to be one of nature's little ironies.
I would submit that men who use Propecia are more confident about themselves having taken action against hair loss than those who are sitting around fretting about it. I believe that in the original clinical trials, the incidence of ‘sexual side effects’ was one in 100 men. If none of those who reported ‘issues’ dropped out of the long term trials or use, it must have been something they were willing to deal with. I doubt there was screening to remove any participant who had pre-existing sexual dysfunction in whatever capacity. As we know from Viagra and others, sexual problems are a fact of aging. So if you are aging and using Propecia would not some of that be normal? Face it- you can have all of the libido in the world but if you are bald- are you getting’ any?
Some of what I have read here makes me beyond angry...a very dear and wonderful man I know is suffering, and I do mean suffering, from taking finasteride...the side effects go much further than just saying sexual side effects...he has numbness in his genitals, shrinkage, skin changes which have made his penis feel like rubber, and when he urinates the urine goes all over...he feels like he has the worst flu ever...he is so fatigued and is unable to do ANYTHING except sit or lie down...he can't get together with friends and have fun like a young man should be able to do...the brain fog is horrible and he can't think straight a great deal of the time. This is just a part of the hell he is going through. Go to the PropeciaHelp.com website...you will hear the horror stories...some of these guys only took finasteride for 4 days...4 days!!! And some of them have been suffering far beyond 6 years... Lives have been RUINED...you don't have to have been a man who had major sexual encounters to be devastated by this...any man, no matter how important sexual encounters were in his life, suffers from what finasteride has done to them. What choice do these men have but to try everything possible to cure themselves and when that cure doesn't happen, to just plod along through the rest of their life? I know of one young man who couldn't handle it and he COMMITED SUICIDE...there are others who have spoken of the thought...it doesn't surprise me one bit. Merck caused this to happen, they knew of the long-term problems, YES, THEY DID, and they now need, MUST, fund research for a cure!!! It is NOT okay for these drug companies to sell what ends up being a poison, making their money, and not making things right when lives are ruined.
I forgot to mention...my friend is only 25 years old...just 25...and there are many men younger than this who are suffering...the men who have been ruined by finasteride aren't just older guys who begin losing some of their sexual function due to aging...
Unfortunately the side effects, at least in my case, are true. It is horribly depressing and difficult to live with (or even think about being in any kind of normal relationship), but I'm 26 years old, about 3 years off of Propecia, and still have almost no libido whatsoever. I was perfectly fine before I started taking the drug...the loss of sex drive was very gradual, and once I linked it to Propecia, caused me to stop taking it. Side effects never went away. I would LOVE to have the libido for 8.8 sexual episodes per month...I'm not even close. I don't know what to do at this point.
People,I have nothing to gain here but please find an alternative to this drug. I am now beginning to see the side of effects of this drug after taking it for a year. When I discontinue taking it for more than a day my libido drops and I have a problem getting an erection. Honestly, I had a sex drive that was through the roof. Too much for most women. Now it is maybe 10 % of what it was before.
Note: Saient point either works for Merck or has neer taken this drug.
God bless you all.
I stopped taking Propecia two weeks ago because I'm overseas and didn't bother to take the tablets with me. I wanted to use the time as a bit of a detox and to see whether my pre-Propecia libido returned. I'm pleased to say that I noticed an increase in libido within a few days of stopping. Now I'm more comfortable with sex daily.
So in my individual case, taking Propecia did result in some sexual side effects but they were not as bad as what I've heard about and they went away soon after cessation of medication.
I would also like comment on the ED side of Propecia. ED and low libido are separate issues. If you can get an erection in your sleep or with manual stimulation, they your problem is not Propecia induced ED. If you can get an erection initially but then lose it, then Propecia is not the issue. This is more likely to be psychological. So much of male sexual performance is about being able to relax and confidence. As soon as your start thinking about your erection in the bedroom, you run the risk of losing it and then the problem compounds. You worry more and you lose your erection more.
In my opinion, this is entirely separate from anything Propecia causes. Propecia may cause lowered libido which may result in not being able to or wanting to get an erection/has sex. But once you have an erection, you can't blame Propeica. However, male sexual performance is very quite complex animal. Take it from a guy who has has ED before taken Propecia and beaten it.
I think that this survey has a heavy selection bias, but I agree with Insider, the reduction in DHT has got to have a negative affect on sexual desire. That's just logical and that has also been my own experience. But I'm also quick to point out that, because male sexual function and libido is so complex and largely psychological, exactly how much of a part Propecia plays is almost impossible to determine.
Like the man says, "A lit dab will do ya".
http://www.bing.com/images/search?q=photo+of+kojak&view=detail&id=668654C9A72FB3F8A4F62606F9EA9E2F0530D587&first=1